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The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), or who fail IV t-PA therapy, are candidates for treatment.

The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The Tigertriever Revascularization Device's performance was evaluated against specific criteria established through a clinical trial (the TIGER study), with a performance goal derived from several other successful stroke device trials.

Table 1: Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that "the TIGER study was successfully met all pre-defined success criteria." The reported performance for both primary endpoints falls within the predefined acceptable ranges/thresholds.

Study Details for Device Performance

The clinical study conducted to demonstrate the device meets the acceptance criteria is the TIGER (Treatment with Intent to Generate Endovascular Reperfusion) clinical trial.

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: 148 patients in the modified Intent-to-Treat (mITT) Cohort.
   • Data Provenance: Not explicitly stated, but it is a multi-center clinical trial. Given the nature of medical device trials and FDA submissions, it would be considered prospective data collection. The document does not specify the country of origin of the data, but the sponsor is Rapid Medical Ltd. (Israel).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Ground Truth for Effectiveness (revascularization): The revascularization (mTICI scores) were adjudicated by a Core Laboratory. The number and specific qualifications of the experts within this Core Laboratory are not provided in this document.
   • Ground Truth for Safety (sICH): The symptomatic intracranial hemorrhage (sICH) events were adjudicated by the Clinical Events Committee (CEC). The number and specific qualifications of the experts within this CEC are not provided in this document.

3. Adjudication method for the test set:

   • Effectiveness (mTICI): Adjudicated by a Core Laboratory (specific method like 2+1 not detailed).
   • Safety (sICH): Adjudicated by a Clinical Events Committee (CEC) (specific method like 2+1 not detailed).

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This document describes a clinical trial for a physical medical device (thrombus retriever), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed or relevant in this context.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • No. This device is a manual thrombus retriever, requiring direct human intervention and skill in its operation. There is no "algorithm only" performance component to be evaluated in a standalone manner.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Clinical Outcomes Data:
     • Revascularization (mTICI score): Based on angiographic imaging, adjudicated by a Core Laboratory (implies expert consensus).
     • Clinical Outcome (mRS ≤ 2 at 90 days): Direct patient outcome survey/assessment.
     • Safety (Mortality, sICH): Patient outcome data and clinical assessment, with sICH adjudicated by a Clinical Events Committee (implies expert consensus based on imaging and clinical presentation).

7. The sample size for the training set:

   • As this is a physical medical device used for treatment and not an AI/machine learning algorithm, there is no concept of a "training set" in the typical sense. The "training" for the device's design and preclinical development would come from engineering principles, in vitro testing, and animal studies, rather than a data-driven training set.

8. How the ground truth for the training set was established:

   • Not applicable as there is no "training set" in the context of an AI algorithm. The device's efficacy and safety were established through a combination of engineering design, non-clinical bench testing, pre-clinical animal testing, and finally, a human clinical trial.

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